STRIDES PHARMA INC Recalls Children's Ibuprofen Oral Suspension
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
STRIDES PHARMA INC Recalls Children's Ibuprofen Oral Suspension
STRIDES PHARMA INC · Class II — Moderate Risk

Product Description
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Reason for Recall
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S.A. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. STRIDES PHARMA INC initiated the recall on March 2, 2026 affecting 89592 bottles. Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. The product was distributed in U.S.A. Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact STRIDES PHARMA INC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.